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Study terminated by Sponsor.
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This is an open-label, non-randomized, interventional, single group assignment study of GDA-201, an allogeneic cryopreserved Natural Killer (NK) cell therapy derived from donor peripheral blood, in combination with rituximab, monoclonal anti-CD20 antibody, for patients with relapsed or refractory B Cell non-Hodgkin lymphoma (NHL).
The study is divided into a phase I dose escalation phase and a phase II expansion phase.
Patients with relapsed or refractory follicular lymphoma (FL) or diffuse large B-cell lymphoma (DLBCL)/high grade B-cell lymphoma (HGBCL) will receive GDA-201 followed by a short course of low-dose interleukin-2 (IL-2). Rituximab will be administered prior to and after GDA-201 infusion.
Phase I: Dose escalation phase The objective of Phase I is to evaluate the safety of GDA-201 in patients with FL, DLBCL/ HGBCL, marginal zone lymphoma or mantle cell lymphoma. The maximal tolerated dose (MTD) and recommended Phase II Dose (RP2D) will be determined based on dose limiting toxicities (DLT).
Phase II expansion phase The objective of the Phase II expansion cohort is to evaluate the safety and efficacy of GDA-201 in two patient cohorts, FL and DLBCL/HGBCL.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GDA-201 Cohort 1 (Phase I) | Other | Dose escalation with up to 4 dose levels to reach MTD and determine recommended Phase II dose (RP2D). |
|
| GDA-201 Cohort 2 (Phase II) | Other | RP2D will be administered to all patients. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GDA-201 | Drug | NAM-expanded allogeneic NK cells |
|
| Measure | Description | Time Frame |
|---|---|---|
| Phase I: Safety as Determined by Dose Limiting Toxicities (DLTs) | DLTs defined as one of the following within the first 28 days of the first dose of GDA-201 by the NCI-CTCAE v 5.0. acute graft-versus-host disease (aGvHD) will be assessed according to the Consensus Conference on aGvHD grading: Steroid refractory Grade II aGvHD, defined as GvHD that does not respond to at least 1 mg/kg/day or equivalent of prednisone within 7 days of initiating therapy Grade III or IV aGvHD Grade 4 infusion reaction Grade 4 or 5 related adverse event (AE) Grade 3 or above cardiac, central nervous system or pulmonary adverse event. Any Grade 3 or above non-hematologic adverse event that does not resolve to Grade 2 or below within 72 hours, except for renal or hepatic adverse events which may take up to 7 days to resolve Treatment emergent ≥Grade 3 autoimmune disorder Grade 3 or above allergic reaction that does not recover to Grade II or below within 24 hours Grade 4 cytopenia lasting beyond Day 42 (the 28-day DLT observation period will be extend | Day 28 |
| Phase II: Overall Response Rate | Patients will be assessed after the infusion of GDA-201 for level of response. | up to 1 year |
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Inclusion Criteria:
Patients must have relapsed/refractory FL or HGBCL/DLBCL that has failed conventional therapy defined as follows:
Patients must be at least 18 years of age
Patients must have adequate hematologic, hepatic, renal, cardiac and pulmonary function prior to any study treatment.
Exclusion Criteria:
Central Nervous System (CNS) lymphoma
Time between previous treatment and first dose of study treatment (rituximab):
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic Jacksonville | Jacksonville | Florida | 32224 | United States | ||
| Loyola University, Cardinal Bernardin Cancer Center |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1 (Phase I) -Dose Level 1 | Phase I dose escalation with up to 4 dose levels to reach maximum tolerated dose (MTD) and determine recommended Phase II dose (RP2D). Dose Level 1: GDA-201 2.5x10^7 cells/kg given in one administration (Day 0) Patients followed up to 1y, or death or disease progression, whichever comes first |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Dose Level 1 (Week 1 to Week 52) |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 2, 2023 |
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Dose escalation cohort 1 to reach the maximal tolerated dose, followed by cohort 2 using the recommended Phase II Dose
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| Maywood |
| Illinois |
| 60153 |
| United States |
| Dana-Farber/Mass General Brigham Cancer Care, Inc. | Boston | Massachusetts | 02215 | United States |
| Henry Ford Medical Center | Detroit | Michigan | 48202 | United States |
| Regents of the University of Minnesota | Minneapolis | Minnesota | 55455 | United States |
| Memorial Sloan Kettering Cancer Center (MSKCC) - Memorial Hospital | New York | New York | 10065 | United States |
| Cohort 1 (Phase I) - Dose Level 2 |
Phase I dose escalation with up to 4 dose levels to reach MTD and determine recommended Phase II dose (RP2D). Dose Level 2: GDA-201 5x10^7 cells/kg given in one (Day 0) or 2 (Day 0 and Day 2) administration(s) Patients followed up to 1y, or death or disease progression, whichever comes first |
| FG002 | Cohort 1 (Phase I) - Dose Level 3 | Phase I dose escalation with up to 4 dose levels to reach MTD and determine recommended Phase II dose (RP2D). Dose Level 3: GDA-201 1x10^8 cells/kg given in two administrations (Day 0 and Day 2) Patients followed up to 1y, or death or disease progression, whichever comes first |
| FG003 | Cohort 1 (Phase I) - Dose Level 4 | Phase I dose escalation with up to 4 dose levels to reach MTD and determine recommended Phase II dose (RP2D). Dose Level 4: GDA-201 2x10^8 cells/kg given in two administrations (Day 0 and Day 2) Patients followed up to 1y, or death or disease progression, whichever comes first |
| COMPLETED |
|
| NOT COMPLETED |
|
| Dose Level 2 (Week 23 - Week 75) |
|
| Dose Level 3 (Week 40 - Week 92) |
|
| Dose Level 4 (Week 62 - Week 114) |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | GDA-201 - Cohort 1 (Phase I) - Dose Level 1 | Phase I dose escalation with up to 4 dose levels to reach MTD and determine recommended Phase II dose (RP2D). Dose Level 1: GDA-201 2.5x10^7 cells/kg |
| BG001 | GDA-201 - Cohort 1 (Phase I) - Dose Level 2 | Phase I dose escalation with up to 4 dose levels to reach MTD and determine recommended Phase II dose (RP2D). Dose Level 2: GDA-201 5x10^7 cells/kg |
| BG002 | GDA-201 - Cohort 1 (Phase I) - Dose Level 3 | Phase I dose escalation with up to 4 dose levels to reach MTD and determine recommended Phase II dose (RP2D). Dose Level 3: GDA-201 2.5x10^8 cells/kg |
| BG003 | GDA-201 - Cohort 1 (Phase I) - Dose Level 4 | Phase I dose escalation with up to 4 dose levels to reach MTD and determine recommended Phase II dose (RP2D). Dose Level 4: GDA-201 5x10^8 cells/kg |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Patient diagnosis | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Phase I: Safety as Determined by Dose Limiting Toxicities (DLTs) | DLTs defined as one of the following within the first 28 days of the first dose of GDA-201 by the NCI-CTCAE v 5.0. acute graft-versus-host disease (aGvHD) will be assessed according to the Consensus Conference on aGvHD grading: Steroid refractory Grade II aGvHD, defined as GvHD that does not respond to at least 1 mg/kg/day or equivalent of prednisone within 7 days of initiating therapy Grade III or IV aGvHD Grade 4 infusion reaction Grade 4 or 5 related adverse event (AE) Grade 3 or above cardiac, central nervous system or pulmonary adverse event. Any Grade 3 or above non-hematologic adverse event that does not resolve to Grade 2 or below within 72 hours, except for renal or hepatic adverse events which may take up to 7 days to resolve Treatment emergent ≥Grade 3 autoimmune disorder Grade 3 or above allergic reaction that does not recover to Grade II or below within 24 hours Grade 4 cytopenia lasting beyond Day 42 (the 28-day DLT observation period will be extend | Posted | Count of Participants | Participants | Day 28 |
|
|
| ||||||||||||||||||||||||||||||||||||
| Primary | Phase II: Overall Response Rate | Patients will be assessed after the infusion of GDA-201 for level of response. | Study was early terminated by Sponsor prior to initiation of the phase II | Posted | up to 1 year |
|
|
Adverse events were collected between initiation of study treatment until end of study participation for each patient (up to one year, or death/disease progression/early termination, whichever came first).
Any event after written informed consent has been obtained and prior to study treatment initiation was recorded as medical history unless the event was directly related to a screening procedure, in such case it was considered an Adverse Event (AE)/Serious adverse event (SAE)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | GDA-201 Cohort 1 (Phase I) - Dose Level 1 | Phase I dose escalation with up to 4 dose levels to reach MTD and determine recommended phase II dose (RP2D). Dose Level 1: GDA-201 2.5x10^7 cells/kg given in one administration (Day 0) | 0 | 4 | 2 | 4 | 4 | 4 |
| EG001 | GDA-201 Cohort 1 (Phase I) - Dose Level 2 | Phase I dose escalation with up to 4 dose levels to reach MTD and determine recommended phase II dose (RP2D). Dose Level 2: GDA-201 5x10^7 cells/kg given in one (Day 0) or two (Day 0 and +2) administrations | 0 | 3 | 1 | 3 | 3 | 3 |
| EG002 | GDA-201 Cohort 1 (Phase I) - Dose Level 3 | Phase I dose escalation with up to 4 dose levels to reach MTD and determine recommended phase II dose (RP2D). Dose Level 3: GDA-201 5x10^7 cells/kg given in two administrations (Day 0 and +2) | 0 | 3 | 1 | 3 | 3 | 3 |
| EG003 | GDA-201 Cohort 1 (Phase I) - Dose Level 4 | Phase I dose escalation with up to 4 dose levels to reach MTD and determine recommended phase II dose (RP2D). Dose Level 4: GDA-201 5x10^7 cells/kg given in two administrations (Day 0 and +2) | 0 | 3 | 0 | 3 | 3 | 3 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Biliary obstruction | Hepatobiliary disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Pain | General disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Generalised edema | General disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Disease progression | General disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal distention | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA (21.0) | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Anemia | Blood and lymphatic system disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA (21.0) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA (21.0) | Systematic Assessment |
| |
| Breast swelling | Reproductive system and breast disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Catheter site pain | General disorders | MedDRA (21.0) | Systematic Assessment |
| |
| chills | General disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Coronavirus infection | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Culture urine positive | Investigations | MedDRA (21.0) | Systematic Assessment |
| |
| Cytokine release syndrome | Immune system disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Disease progression | General disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Head discomfort | Nervous system disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Hepatobiliary procedural complication | Injury, poisoning and procedural complications | MedDRA (21.0) | Systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Hypermagnesaemia | Metabolism and nutrition disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Hypervolaemia | Metabolism and nutrition disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Incontinence | Renal and urinary disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA (21.0) | Systematic Assessment |
| |
| Infusion site pain | General disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Injection site pain | General disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Injection site reaction | General disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Lethargy | Nervous system disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Lymph node pain | Blood and lymphatic system disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Neuralgia | Nervous system disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA (21.0) | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Pain | General disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Parainfluenzae virus infection | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA (21.0) | Systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA (21.0) | Systematic Assessment |
| |
| Proctalgia | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Rectal discharge | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Restlessness | Psychiatric disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Synovial cyst | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Throat tightness | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Tinea cruris | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
| |
| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (21.0) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Vocal cord paralysis | Nervous system disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA (21.0) | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA (21.0) | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Associate director, Clinical Operations | Gamida Cell | +972556660324 | aurelie@gamida-cell.com |
| Feb 11, 2025 |
| Prot_SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D016393 | Lymphoma, B-Cell |
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D009536 | Niacinamide |
| ID | Term |
|---|---|
| D009539 | Nicotinic Acids |
| D000147 | Acids, Heterocyclic |
| D006571 | Heterocyclic Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Diffuse large B-cell lymphoma |
|
| High grade B-cell lymphoma |
|
| Marginal zone lymphoma |
|
| Mantle cell lymphoma |
|
| Patients who did not experience DLT |
|
| Patients not evaluable for DLT |
|